Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT05299489
Collaborator
(none)
20
1
2
16
1.2

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effectiveness of direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH) and following up after 3 , 6 , 12 months (Clinically):

Group A ( Control group ): Hypomineralization molars were restored by direct composite.

Group B ( Experimental group ): Hypomineralization molars were restored by indirect composite.

Condition or Disease Intervention/Treatment Phase
  • Other: Direct restoration
  • Other: Indirect restoration
N/A

Detailed Description

Pediatric dentists face a high prevalence of MIH ranging from 3 to 40%, so it is relatively common condition that would cause treatment challenges due to severe sensitivity, breakdown of the occlusal surface, difficulty anesthesia and relatively high failure of restorations as a result of marginal breakdown of restorations.

There are many treatment options available to restore these teeth. In mild and moderate cases, they are restored using direct composite resin. In cases where teeth are severely affected, the treatment is more complicated, including stainless steel crowns and different types of full or partial indirect crowns.

Direct composite resin restorations are the treatment option in the majority of clinical cases, but in severe cases, the results of treatment are often unsatisfactory.

Indirect composite restorations are an aesthetic alternative to cast metal inlays and stainless steel crowns with minimal microleakage.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Split mouth designSplit mouth design
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Randomized Controlled Trial To Compare Direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH)
Actual Study Start Date :
Oct 15, 2020
Actual Primary Completion Date :
Dec 25, 2021
Actual Study Completion Date :
Feb 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Direct composite in hypomineraliztion molars.

Other: Direct restoration
Local anesthesia was achieved and the tooth were isolated using a rubber dam. Then, the entire caries and hypomineralized enamel were removed using diamond burs and removal the affected dentine caries by slow speed handpiece, the final preparation must be on intact enamel. The molars were wiped using 5.25% sodium hypochlorite followed by rinsing with water, etching using 37% phosphoric acid The surface of the restoration, bonding, applying composite and assessment of occlusion.

Other: Indirect composite in hypomineraliztion molars.

Other: Indirect restoration
Local anesthesia was achieved and the tooth were isolated using a rubber dam. Then, the entire caries and hypomineralized enamel were removed using diamond burs and removal the affected dentine caries by slow speed handpiece, the final preparation must be on intact enamel. Preparation walls were vertical according to the longitudinal axis of the tooth and the occlusal depth 2 mm. The impressions were taken for both jaws and the bite were recorded for the using red wax. The cavity in example were painted with insulating material. Indirect composite resin were applied, finishined and polished. Cementation: Tooth surface: The molars were wiped using 5.25% sodium hypochlorite followed by rinsing with water, etching using 37% phosphoric acid The surface of the restoration: application of silane coupling agent to enhance the formation of resin tags. Dual cure resin cement was used for final cementation followed by an assessment of occlusion.

Outcome Measures

Primary Outcome Measures

  1. Clinical evaluation of teeth restored by direct composite. [3 months after applying the restoration]

    Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

  2. Clinical evaluation of teeth restored by direct composite. [6 months after applying the restoration]

    Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

  3. Clinical evaluation of teeth restored by direct composite. [12 months after applying the restoration]

    Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

  4. Clinical evaluation of teeth restored by indirect composite. [3 months after applying the restoration]

    Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

  5. Clinical evaluation of teeth restored by indirect composite. [6 months after applying the restoration]

    Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

  6. Clinical evaluation of teeth restored by indirect composite. [12 months after applying the restoration]

    Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following: Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age between 8 and 12 years.

  2. Definitely positive or positive ratings of Frank scale.

  3. The first permanent molars must achieve the following criteria: The molar must be suffering from severe demineralization and it must be restorable with composite.

  4. caries lesions include the occlusal surface and should not extend more than thirds of the thickness of dentin

  5. Absence clinical and radiographic signs which indicate pulp necrosis

Exclusion Criteria:
  1. Systematic or mental disorders.

  2. Definitely negative or negative ratings of Frankel scale

  3. Existence periapical translucence

  4. Existence external or internal abnormal absorption

  5. Existence swelling or fistula

  6. Sensitivity to percussion

  7. Existence of spontaneous or stimulant pain

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damascus University Damascus Syrian Arab Republic

Sponsors and Collaborators

  • Damascus University

Investigators

  • Principal Investigator: Abdulrhman S Hakmi, MSc student in Pedodontics, University of Damascus
  • Study Director: Mayssoon Dashash, Phd, Professor of Pedodontics, Department of Pedodontics, University of Damascus

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT05299489
Other Study ID Numbers:
  • UDDS-Pedo-10-2022
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damascus University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022